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U.S. Department of Health and Human Services

Class 2 Device Recall Surge Medical Solutions Retrograde Cardioplegia Cannula

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  Class 2 Device Recall Surge Medical Solutions Retrograde Cardioplegia Cannula see related information
Date Initiated by Firm April 17, 2007
Date Posting Updated June 06, 2007
Recall Status1 Terminated 3 on March 10, 2009
Recall Number Z-0892-2007
Recall Event ID 37806
510(K)Number K964393  
Product Classification Cannula, cardioplegia - Product Code DWF
Product Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S.
Code Information All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702.
Recalling Firm/
Surge Medical Solutions, LLC
3710 Sysco Court S.E.
Grand Rapids MI 49512
For Additional Information Contact Ray Lokers
Manufacturer Reason
for Recall
The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
FDA Determined
Cause 2
Action Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.
Quantity in Commerce 2,211 for all Recalls Z-0892-0904-2007
Distribution Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = CHASE MEDICAL, INC.